The purpose of this study was to determine whether mechanical compression of the cornea during corneal crosslinking for keratoconus using a sutured rigid contact lens can improve the optical outcomes of the treatment.
The study is designed as a prospective, open, randomized controlled trial involving patients aged 18-28 years of both genders with uni- or bilateral keratoconus planned for routine corneal crosslinking at the Department of Ophthalmology, Umeå University Hospital, Umeå, Sweden. The study involves 30+30 eyes with keratoconus, which are randomized to receive either conventional corneal crosslinking (n=30) using the Dresden protocol or a modified treatment - corneal reshaping and crosslinking (n=30), where a rigid contact lens is sutured to the cornea during the treatment to flatten the corneal curvature and potentially improve the optical outcome after the treatment. Patients are randomized utilizing a list of unique random numbers between 1 and 60. All patients are informed about the procedures before consenting to participate in the study. The study also involves 60 eyes of healthy age- and sex-matched control subjects. At baseline, before treatment, each eye is evaluated with autorefractometer measurement, best spectacle-corrected LogMAR visual acuity, Pentacam Scheimpflug photography, Goldmann applanation tonometry and biomicroscopy. The corneal biomechanical characteristics are assessed with applanation resonance tonometry and the ocular response analyzer. The investigations are repeated at 1 month, 6 months, 2 years and 5 years after the treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
Change from baseline in refraction
Refractive errors, including lower and higher order aberrations in the cornea
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in ETDRS LogMAR visual acuity
Uncorrected and best spectacle corrected visual acuity measured with the Early treatment diabetic retinopathy study, graded in logarithmic values of the minimal angle of resolution
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ORA
Biomechanical stability assessed with the ocular response analyzer
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with ART
Biomechanical stability assessed with the applanation resonance tonometer
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal biomechanical stability measured with GAT
Biomechanical stability assessed with the Goldmann applanation tonometer
Time frame: 1, 6, 24 and 60 months after the treatment
Change from baseline in corneal densitometry
Corneal light reflectivity (back scatter) assessed with the Pentacam HR Scheimpflug camera
Time frame: 1, 6, 24 and 60 months after the treatment
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